AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Bruno Bockorny
Study ID
NCT05632328
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AGEN1423 — DRUG
    via IV, dosage per protocol, once every 2 weeks for up to 8 weeks
  • Botensilimab — DRUG
    via IV, dosage per protocol, once evert 2 weeks, up to 2 years
  • Gemcitabine — DRUG
    per standard care
  • Nab-paclitaxel — DRUG
    per standard care

Study Details

The goal of this research study is to asses the safety and efficacy of the combination of AGEN1423 and Botensilimab with or without chemotherapies, gemcitabine and nab-paclitaxel, for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) which has progressed after at least one previous line of cancer therapy. The names of the study drugs involved in this study are: * AGEN1423 * Botensilimab Participants will receive study treatment for about 2 years and will be followed for 1 year after.

Key Dates

Start date
Aug 8, 2024
Status verified
Apr 2026
Primary completion
May 1, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: COHORT 1: AGEN1423 Plus Botensilimab
    Treatment is AGEN1423 plus Botensilimab for 4 cycles (8 weeks) followed by Botensilimab alone for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Botensilimab will be administered every 2 weeks.
  • Experimental: COHORT 2: AGEN1423 Plus Botensilimab and Chemotherapy
    Treatment is AGEN1423 plus Botensilimab in combination with gemcitabine and nab-paclitaxel for 2 cycles (8 weeks) followed by Botensilimab in combination with gemcitabine and nab-paclitaxel for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Botensilimab will be administered once every 2 weeks.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Every 8 weeks until EOT, for up to 2 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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